Published PARTNER Results Confirm TAVI Option

Action Points

Note that surgical aortic valve replacement and transcatheter replacement were associated with similar mortality and similar improvements in cardiac symptoms.

Point out, however, that there were significant differences in the types of complications associated with each procedure, and so it is important to individualize recommendations based on these differences and clinical benefits.

At one year there were no significant survival differences among high-risk patients who underwent transcatheter aortic valve replacement (TAVI) compared with those who had surgical repair, but there were significant differences in adverse events at 30 days, according to results of the PARTNER trial.

Patients in the TAVI group were more likely to have major vascular complications at 30 days (11% versus 3.2% P<0.001) but both major bleeding (9.3% versus 19.5% P<0.001) and new onset atrial fibrillation (8.6% versus 16% P<0.001) were more common in the surgical group, wrote Craig R. Smith, MD, of Columbia University Medical Center-New York Presbyterian Hospital in New York City, and colleagues.

The results, which reflect cohort A of the PARTNER trial, were published online by the New England Journal of Medicine.

The rate of major strokes was 3.8% in the TAVI -- or TAVR as it is also called -- arm versus 2.1% in the surgery arm at 30 days and 5.1% versus 2.4% at one year, differences that were not statistically significant (P=0.20 at 30 days and 0.07 at one year).

When strokes and transient ischemic attacks were considered together there was a statistically significant benefit favoring surgery at both 30 days and one year (P=0.04).

"Our findings indicate that transcatheter replacement is an alternative to surgical replacement in a well-chosen, high-risk subgroup of patients with aortic stenosis," Smith wrote.

"In the absence of long-term follow-up data, recommendations to individual patients must balance the appeal of avoiding the known risks of open-heart surgery against the less invasive transcatheter approach, which has different and less well understood risks, particularly with respect to stroke."

In an editorial that accompanied the published results, Hartzell V. Schaff, MD, of the Mayo Clinic in Rochester, Minn., wrote that the issue of neurologic complications is worrisome, especially among patients who "are candidates for either transcatheter or surgical replacement."

The increased risk of cerebrovascular events was not surprising, Schaff wrote, since in high-risk patients calcifications "in aortic-valve cusps are usually covered by endothelium, but dilatation of the valve may lead to fracture of the calcified portion and exposure to circulation."

Even a simple procedure such as passing a catheter across a calcified valve "can cause emboli."

Schaff concluded that it may be possible to further refine TAVI with the use of embolic protection devices, but more carefully designed trials are needed to confirm that hypothesis.

The trial recruited 699 high-risk older patients with severe aortic stenosis and randomly assigned them to TAVI (n=348) or surgery.

In the TAVI group, roughly two-thirds of the patients underwent transfemoral procedures and 103 had transapical access procedures. All patients in the TAVI group received the Sapien heart-valve system made by Edwards Lifesciences.

Of the 699 patients recruited, 42 did not undergo the assigned procedure (just four in the TAVI group). In most cases these patients either withdrew from the study or decided not to undergo surgery.

The authors noted that the rate of withdrawals and decisions to decline surgery, were unexpectedly high, and, as a result, "a balanced perspective on early procedure-related outcomes requires analysis of both intention-to-treat and as-treated study populations," which is a limitation of the study.

Additionally, one year of data are not sufficient to assess the durability of the prosthetic valves, and the trial used an early version of the transcatheter device, "predominantly in centers with no previous experience with the procedure."

Finally, and most importantly, the trial was not powered to reach "robust conclusions with respect to specific subgroups of patients, including any possible differences in outcome between the transapical and the transfemoral procedures."

The cohort A PARTNER was the second of two PARTNER cohorts to be reported.

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